Off-drug use refers to the practice of prescribing a drug for an unapproved indication, or in an unapproved age, dosage, or route of administration, differing from what the FDA initially authorized. It is a common and multiplex practice that has existed in the healthcare field for years. It is estimated that 21% to 32.3% of all prescriptions, and up to 97% in specific populations, are for off-label uses, indicating its widespread use. While it can offer notable treatment alternatives, it can trigger both legal and ethical challenges. Taking this into account, an attempt was made to examine the off-label development background, the regulatory framework surrounding it, and the ethical dilemmas it raises. It explores the impacts of off-label prescribing on sensitive fields such as pediatrics, oncology, and rare diseases, where off-label use carries both significant benefits and risks. Moreover, the thesis highlights differences in legal frameworks by analyzing regulatory policies in the EU and US, while describing the fundamental role of informed consent, transparency, and professional integrity in protecting patient autonomy and wellbeing. The ethical principles of beneficence, non-maleficence, and justice are further investigated affecting the medical decision-making process and patient care. Combing these theoretical insights, a survey was conducted among healthcare professionals, to capture their perspectives on off-label drug use. The results underscored the necessity for clearer legal guidance, better education, and standardized protocols to create ethical and responsible off-label prescribing. In order to ensure off-label treatments are in line with ethical and legal standards, the thesis concludes by proposing a balanced strategy that combines thorough research, equal access, and a patient-centered focus.
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